The Recall Desk

Hazard

Mis Labeling recalls

9,607 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,607
Critical
160
Severe
588
Most recent
2026-09-10

Of the 9,607 mis labeling recalls we have scored against our rubric, 160 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 588 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis labeling recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

3676–3700 of 9607

  • ModerateFDA (Devices)·Z-1462-2018·2018-05-02

    Howmedica Triathlon Revision Knee Implants Recalled for Sizing Errors

    Howmedica Osteonics Corp. is recalling 77 Triathlon Revision Knee implants because customers may receive the incorrect size from what is labeled on the box.

    Product
    Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2018·2018-05-02

    Stryker Recalls 18 Hinge Coupling Units Due to Packaging Error

    Stryker GmbH is recalling 18 Hinge Coupling Hoffmann LRF units because connecting nuts were incorrectly packed in hinge coupling packaging.

    Product
    Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2018·2018-05-02

    Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch

    Zimmer GmbH is recalling specific Avenir Muller Stem implants because a potential commingle may cause the product in the package to not match the outer label.

    Product
    Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1534-2018·2018-05-02

    Ethicon Recalls Evicel Fibrin Sealant Accessory Tips Due to Distribution Error

    Ethicon is recalling Evicel Accessory Device 45 cm Flexible Tips because products labeled for foreign distribution may have been distributed in the US.

    Product
    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1521-2018·2018-05-02

    Cook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error

    Cook Inc. is recalling 40 Advance 35LP Low-Profile PTA Balloon Dilatation Catheters because some units were packaged with incorrect size labels.

    Product
    Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous translumin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2018·2018-05-02

    Roche Acetaminophen Assay Method Sheets Missing Interference Statement

    Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.

    Product
    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1518-2018·2018-05-02

    CooperVision Clariti 1 Day Contact Lenses Recalled for Incorrect Expiration Date

    CooperVision is recalling specific lots of Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1479-2018·2018-05-02

    Medtronic DxTerity Diagnostic Catheter Recalled for Incorrect Box Labeling

    Medtronic is recalling 855 units of DxTerity Diagnostic Catheters because the outer box displays an incorrect 6 French size indicator, though the catheters inside are correct.

    Product
    Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1515-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1517-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1464-2018·2018-05-02

    Ace Surgical Supply Recalls Mispackaged Double Blade Shoe Unigraft Knives

    Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knives because a single blade shoe was mistakenly packaged instead of the intended double blade.

    Product
    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1520-2018·2018-05-02

    Quidel MicroVue Intact PTH EIA Recalled for Potential Calibration Issues

    Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.

    Product
    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1516-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveamet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V270000·2018-04-27

    Forest River Prime Time Recalled for Incorrect Weight Rating Placard

    Forest River is recalling 2018 Prime Time WCF35MB trailers because the Federal Placard lists an incorrect Gross Vehicle Weight Rating, which could lead to overloading and increased crash risk.

    Product
    FOREST RIVER — FOREST RIVER PRIME TIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1014-2018·2018-04-25

    Scotcharoo Valanga Gourmet Recalled for Missing Milk and Soy Allergen Labels

    Avalanche Distributing is recalling Scotcharoo Valanga Gourmet because the packaging fails to declare milk and soy in the 'Contains' statement, despite listing these ingredients.

    Product
    Scotcharoo Valanga Gourmet, is a crispy rice cereal with peanut butter base, with semisweet chocolate and butterscotch melted on top. Individually wrapped, sold in boxes of 12. Net Wt. 3.2 oz (91g). UPC 814524611556. The product label is read in parts: "***VALANGA GOURMET Sco
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1385-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart mu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2018·2018-04-25

    GE Healthcare Lunar DPX Bone Density Systems Recalled for Data Errors

    GE Healthcare is recalling 43 Lunar DPX bone density systems because patient reports may be sent to hospital systems with incorrect names in the header.

    Product
    GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2018·2018-04-25

    GE Healthcare Lunar DPX Duo and Bravo Bone Density Software Recall

    GE Healthcare is recalling Lunar DPX Duo and Bravo bone density scanners because a software issue may cause reports to be filed under the wrong patient name in the hospital system.

    Product
    GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2018·2018-04-25

    Terumo Sarns TCM II Recall for Updated Cleaning Instructions

    Terumo is recalling Sarns TCM II devices to update cleaning instructions. The recall covers 2,393 units distributed worldwide.

    Product
    Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2018·2018-04-25

    GE Healthcare Prodigy Ultrasound Recall for Incorrect Patient Data in Reports

    GE Healthcare is recalling Prodigy and Prodigy Advanced ultrasound systems because bone density exam reports may be sent to PACS with incorrect patient information in the DICOM header.

    Product
    GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 Provides an estimate of BMD (Bone Marrow Density) at t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2018·2018-04-25

    Fluconazole Injection Recalled Due to Labeling Mix-Up

    Renaissance Lakewood, LLC is recalling Fluconazole Injection due to a labeling mix-up where a 50 mL bag was found in a 100 mL package.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, I
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1444-2018·2018-04-25

    TMJ Solutions Recalls Misidentified Right Mandibular Component

    TMJ Solutions Inc is recalling a specific right mandibular component of a TMJ Reconstruction Prosthesis System because it was mislabeled and is not the correct component for the intended patient.

    Product
    Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibu
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1386-2018·2018-04-25

    Southern Implants Recalls Dental Implants Due to Inner Labeling Error

    Southern Implants is recalling 49 dental implant units because the inner label incorrectly identifies the product reference number.

    Product
    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
    Category
    Medical Device
    Distribution
    0 states